EMD Serono Presents New MAVENCLAD ® (Cladribine) Tablets Data Highlighting Sustained Reduction in NfLs and Benefit of Early Initiation

New data showed sustained reduction in neurofilament light chain (NfL) levels over two years of treatment with MAVENCLAD® (cladribine) tablets in patients with relapsing multiple sclerosis (RMS) Findings from real-world evidence (RWE) studies suggest a shift toward the use of cladribine tablets in treatment-naïve RMS patients with high rates of treatment continuation at four years EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of new analyses from the MAVENCLAD® (cladribine) tablets MAGNIFY-MS study, which demonstrated that patients with relapsing multiple sclerosis (RMS) experienced sustained reduction in serum neurofilament light chain (NfL), indicating that MAVENCLAD reduced neuronal injury over two years. Additional data include two real-world evidence (RWE) studies, which indicated an increase in the use of cladribine tablets in treatment-naïve patients and demonstrated low levels of switching to other disease-modifying therapies (DMTs) up to four years. These data were presented at the 9th Joint ECTRIMS-ACTRIMS meeting in Milan, Italy. Analyses from the post-hoc MAGNIFY-MS study showed that throughout the two-year treatment course of MAVENCLAD, median serum NfL Z-scores were reduced in all patient groups compared to baseline. These findings suggest that MAVENCLAD effectively reduced neuronal injury across magnetic resonance imaging (MRI) outcome subgroups. “Our commitment to the MS community drives our unwavering focus on generating data that provide further insights into the efficacy and safety of MAVENCLAD,” said Alexander Kulla, Senior Vice President & Medical Unit Head Neurology & Immunology at Merck KGaA, Darmstadt, Germany. “We know that serum NfL levels are increasingly used as an important biomarker in MS, signaling possible disease activity that can lead to progression. The findings presented at ECTRIMS-ACTRIMS demonstrate that MAVENCLAD produced sustained reductions in serum NfL without continuous immunosuppression." Two real-world studies also presented at ECTRIMS-ACTRIMS reinforce the potential benefits of initiating treatment with cladribine tablets in the earlier stages of the disease. In the five-year follow-up of the CLARENCE study, conducted in the United Kingdom, it was found that 36.1% of 2,685 assessed patients were treatment-naïve during treatment commencement. In a separate study out of Latin America, data was analyzed from 1,421 patients who received at least one course of cladribine tablets. Over time, an increasing trend in treatment initiation among treatment-naïve patients was observed, suggesting an advantage of early utilization of cladribine treatment. As well in both studies, very few patients receiving cladribine tablets switched to other therapies.

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